Esophageal Varices in Cirrhosis of the LiverNCT03943784
Endoscopic Variceal Ligation in Children
An observational study of Esophageal Varices in Cirrhosis of the Liver and Upper Gastrointestinal Bleeding, run by Hospital Vall d'Hebron.
Trial summary
This is an ambispective single-center cohort study of pediatric patients with portal hypertension and esophageal varices. The study was designed to evaluate the efficacy and safety of primary prophylaxis with endoscopic variceal ligation to prevent upper gastrointestinal bleeding compared to non-selected beta-blockers… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Esophageal Varices in Cirrhosis of the Liver, Upper Gastrointestinal Bleeding, Endoscopy
- What is being tested?
- Endoscopic Variceal Ligation and Non-Selective Beta-Blocking Agent
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All pediatric patients with a known chronic liver disease with suspicion of portal hypertension who presented grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy from January 2009 to April 2017 that received propranolol or endoscopic variceal ligation as a primary prophylaxis.
Who may be able to join
- All paediatric patients (< 18 years)
- Known chronic liver disease
- Suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (<150.000 platelets/L),
- Grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy
- From January 2014 to April 2017
- All paediatric patients (< 18 years)
Show all 11Show fewer
- Known chronic liver disease
- Suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (<150.000 platelets/L),
- Grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy
- That received propranolol as primary prophylaxis
- From January 2009 to December 2013.
Who cannot join
- Patients initially treated with Non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.
- Patients for whom endoscopic variceal ligation was not feasible because of patients' weight/seize were also excluded of the study.
- Patients initially treated with non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.
About this study
Official title: Endoscopic Variceal Ligation as Primary Prophylaxis for Upper Gastrointestinal Bleeding in Children
This is an ambispective single-center cohort study of pediatric patients with portal hypertension and esophageal varices. The study was designed to evaluate the efficacy and safety of primary prophylaxis with endoscopic variceal ligation to prevent upper gastrointestinal bleeding compared to non-selected beta-blockers prophylaxis.
Read the detailed description
Endoscopic Variceal Ligation group; Inclusion criteria From January 2014 to April 2017, a study group was created, including all paediatric patients with a known chronic liver disease with suspicion of portal hypertension and grade 2 or 3 OV or red spots, regardless of the grade of the OV diagnosed by endoscopy.
Propanolol group Patients in the Endoscopic Variceal Ligation study group were compared with an historical cohort of 30 consecutive patients with portal hypertension and grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices in the upper endoscopy, who received propranolol as primary prophylaxis from January 2009 to December 2013.
Ligation sessions were performed every 6 weeks until varices eradication. When eradication was achieved, upper endoscopy was performed at 2 and 6 months to assess the efficacy of the treatment. If no varices were observed, upper endoscopies were performed once a year thereafter.
Eradication was defined as disappearance of all varices or reduction to grade 1 small varices without reddish spots and no gastric varices.
- Conditions
- Esophageal Varices in Cirrhosis of the Liver, Upper Gastrointestinal Bleeding, Endoscopy, Child
- Being tested
- Endoscopic Variceal Ligation, Non-Selective Beta-Blocking Agent
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Variceal LigationProcedure or surgery
Endoscopic varices ligation was performed with a six-shooter multiband ligator (Cook Medical, Limerick, Ireland) if medium to large varices or reddish spots, regardless of the grade of the varix, were observed. Each varix was ligated 1-2 cm above the gastro-esophageal junction, with 1 or 2 rubber bands and using no more than 5 rubber bands per session.
Non-Selective Beta-Blocking AgentDrug
Also called Propranolol
Patients of the Propranolol group that presented medium to large esophageal varices without contraindication to Non-Selective Beta-Blockers, received propranolol, 1 mg/Kg/day every 8 hours, titrated to reduce the basal heart rate in 25% and not exceeding 5 mg/Kg/day. Patients were evaluated monthly until this reduction in heart rate was achieved, and every three to six months thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Variceal Ligation | From January 2014 to April 2017, all paediatric patients with a known chronic liver disease with suspicion of portal hypertension who presented grade 2 or 3 esophageal varices or red spots in the upper endoscopy received primary prophylaxis with endoscopic variceal ligation. Receives: Procedure: Endoscopic Variceal Ligation | |
| Propranolol Group | Patients in the Endoscopic Variceal Ligation group were compared with an historical cohort of 30 consecutive patients with portal hypertension and grade 2 or 3 esophageal varices or red spots who received propranolol as primary prophylaxis from January 2009 to December 2013. All patients were treatment-naïve in regards of their upper gastrointestinal bleeding prophylaxis at the time of the first upper endoscopy. Receives: Drug: Non-Selective Beta-Blocking Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that present the first episode of Upper Gastrointestinal Bleeding after the use of endoscopic variceal ligation as a prophylactic treatment (Efficacy)
From the moment that the endoscopic variceal ligation was performed, the number of patients that present the first episode of upper gastrointestinal bleeding due to esophageal varices will be recorded
Measured: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
Number of patients that present adverse events related to the use of endoscopic variceal ligation as a prophylactic treatment (Safety)
Hematology and biochemistry parameters and adverse events notified during the study will be recorded in order to evaluate the safety and tolerability of endoscopic variceal ligation as prophylactic treatment of upper gastrointestinal bleeding in pediatric patients
Measured: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
Secondary outcomes (5)
Survival at 1 year after prophylactic treatment (endoscopic or propranolol)
Survival was defined as the time from endoscopic variceal ligation/propranolol start to death due to upper gastrointestinbal bleeding or date of last follow-up, measured in months
Measured: Survival will be reported at 1 year after the start of the prophylactic treatment
Survival at 3 year after prophylactic treatment (endoscopic or propranolol)
Survival was defined as the time from endoscopic variceal ligation/propranolol start to death due to upper gastrointestinbal bleeding or date of last follow-up, measured in months
Measured: Survival will be reported at 3 years after the start of the prophylactic treatment
Transplant-free survival at 1 year
Transplant-free survival was defined as the time from endoscopic variceal ligation or propranolol start to the date of transplantation, measured in months
Measured: Transplant-free survival wil be reported at 1 year after the start of the prophylactic treatment
Transplant-free survival at 3 years
Transplant-free survival was defined as the time from endoscopic variceal ligation or propranolol star to the date of transplantation, measured in months
Measured: Transplant-free survival wil be reported at years after the endoscopic prophylaxis
Esophageal varices eradication with endoscopic treatment
The number of patients that present esophageal varices eradication using endoscopic variceal ligation. Eradication was defined as disappearance of all varices or reduction to grade 1 small varices without reddish spots and no gastric varices.
Measured: From the first episode of variceal ligation to eradication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Jan 2014
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Varices in Cirrhosis of the LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Quintero, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943784
- Sponsor's protocol ID
- 31/2019
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quintero J, Juamperez J, Mercadal-Hally M, King ML, Ortega J, Molino JA, Abu-Suboh M, Dot J, Nuno R, Montferrer N, Armengol JR, Charco R. Endoscopic variceal ligation as primary prophylaxis for upper GI bleeding in children. Gastrointest Endosc. 2020 Aug;92(2):269-275. doi: 10.1016/j.gie.2020.02.035. Epub 2020 Feb 29.
PubMed 32119939
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Variceal Ligation as Primary Prophylaxis for Upper Gastrointestinal Bleeding in Children
- ClinicalTrials.gov ID
- NCT03943784
- Acronym / sponsor ID
- 31/2019
- Conditions
- Esophageal Varices in Cirrhosis of the Liver, Upper Gastrointestinal Bleeding, Endoscopy, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an ambispective single-center cohort study of pediatric patients with portal hypertension and esophageal varices. The study was designed to evaluate the efficacy and safety of primary prophylaxis with endoscopic variceal ligation to prevent upper gastrointestinal bleeding compared to non-selected beta-blockers prophylaxis.
Detailed description
Endoscopic Variceal Ligation group; Inclusion criteria From January 2014 to April 2017, a study group was created, including all paediatric patients with a known chronic liver disease with suspicion of portal hypertension and grade 2 or 3 OV or red spots, regardless of the grade of the OV diagnosed by endoscopy.
Propanolol group Patients in the Endoscopic Variceal Ligation study group were compared with an historical cohort of 30 consecutive patients with portal hypertension and grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices in the upper endoscopy, who received propranolol as primary prophylaxis from January 2009 to December 2013.
Ligation sessions were performed every 6 weeks until varices eradication. When eradication was achieved, upper endoscopy was performed at 2 and 6 months to assess the efficacy of the treatment. If no varices were observed, upper endoscopies were performed once a year thereafter.
Eradication was defined as disappearance of all varices or reduction to grade 1 small varices without reddish spots and no gastric varices.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Variceal Ligation | – | Procedure: Endoscopic Variceal LigationFrom January 2014 to April 2017, all paediatric patients with a known chronic liver disease with suspicion of portal hypertension who presented grade 2 or 3 esophageal varices or red spots in the upper endoscopy received primary prophylaxis with endoscopic variceal ligation. |
| Propranolol Group | – | Drug: Non-Selective Beta-Blocking AgentPatients in the Endoscopic Variceal Ligation group were compared with an historical cohort of 30 consecutive patients with portal hypertension and grade 2 or 3 esophageal varices or red spots who received propranolol as primary prophylaxis from January 2009 to December 2013. All patients were treatment-naïve in regards of their upper gastrointestinal bleeding prophylaxis at the time of the first upper endoscopy. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All pediatric patients with a known chronic liver disease with suspicion of portal hypertension who presented grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy from January 2009 to April 2017 that received propranolol or endoscopic variceal ligation as a primary prophylaxis.
Key inclusion criteria (11 listed)
- All paediatric patients (< 18 years)
- Known chronic liver disease
- Suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (<150.000 platelets/L),
- Grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy
- From January 2014 to April 2017
Key exclusion criteria (3 listed)
- Patients initially treated with Non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.
- Patients for whom endoscopic variceal ligation was not feasible because of patients' weight/seize were also excluded of the study.
- Patients initially treated with non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Variceal LigationEndoscopic varices ligation was performed with a six-shooter multiband ligator (Cook Medical, Limerick, Ireland) if medium to large varices or reddish spots, regardless of the grade of the varix, were observed. Each varix was ligated 1-2 cm above the gastro-esophageal junction, with 1 or 2 rubber bands and using no more than 5 rubber bands per session. | Procedure or surgery | Endoscopic Variceal Ligation |
| Non-Selective Beta-Blocking AgentAlso: PropranololPatients of the Propranolol group that presented medium to large esophageal varices without contraindication to Non-Selective Beta-Blockers, received propranolol, 1 mg/Kg/day every 8 hours, titrated to reduce the basal heart rate in 25% and not exceeding 5 mg/Kg/day. Patients were evaluated monthly until this reduction in heart rate was achieved, and every three to six months thereafter. | Drug | Propranolol Group |
Primary outcome
Number of patients that present the first episode of Upper Gastrointestinal Bleeding after the use of endoscopic variceal ligation as a prophylactic treatment (Efficacy)
Time frame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
From the moment that the endoscopic variceal ligation was performed, the number of patients that present the first episode of upper gastrointestinal bleeding due to esophageal varices will be recorded
Number of patients that present adverse events related to the use of endoscopic variceal ligation as a prophylactic treatment (Safety)
Time frame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
Hematology and biochemistry parameters and adverse events notified during the study will be recorded in order to evaluate the safety and tolerability of endoscopic variceal ligation as prophylactic treatment of upper gastrointestinal bleeding in pediatric patients
5 secondary outcomes
Survival at 1 year after prophylactic treatment (endoscopic or propranolol)
Time frame: Survival will be reported at 1 year after the start of the prophylactic treatment
Survival at 3 year after prophylactic treatment (endoscopic or propranolol)
Time frame: Survival will be reported at 3 years after the start of the prophylactic treatment
Transplant-free survival at 1 year
Time frame: Transplant-free survival wil be reported at 1 year after the start of the prophylactic treatment
Transplant-free survival at 3 years
Time frame: Transplant-free survival wil be reported at years after the endoscopic prophylaxis
Esophageal varices eradication with endoscopic treatment
Time frame: From the first episode of variceal ligation to eradication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Derived from this study: PubMed 32119939Quintero J, Juamperez J, Mercadal-Hally M, King ML, Ortega J, Molino JA, Abu-Suboh M, Dot J, Nuno R, Montferrer N, Armengol JR, Charco R. Endoscopic variceal ligation as primary prophylaxis for upper GI bleeding in children. Gastrointest Endosc. 2020 Aug;92(2):269-275. doi: 10.1016/j.gie.2020.02.035. Epub 2020 Feb 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices in Cirrhosis of the Liver and Upper Gastrointestinal Bleeding, run by Hospital Vall d'Hebron.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that present the first episode of Upper Gastrointestinal Bleeding after the use of endoscopic variceal ligation as a prophylactic treatment (Efficacy) (time frame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03943784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.